Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

Not Applicable

Withdrawn

• Conditions: Dry Eye Syndrome
• Interventions: Device: Lacrima medical Prototypes

• Registration Number: NCT01957670
• Lead Sponsor: Lacrima Medical LTD

Brief Summary

The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Study Start: 2014-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-06
• Last Update Posted: 2016-03-08
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female, 18 years of age and over at screening

2. Diagnosis of mild to moderate Dry Eye, as defined by:

   1. Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND
   2. Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND
   3. OSDI score of ≥12 and OSDI score of <33

Main

Exclusion Criteria

1. Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
2. Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection
3. Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
4. Receipt of any type of topical artificial eye drops within 3 days prior to screening
5. Receipt of topical cyclosporine eye drops within 3 months prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Lacrima medical device	Lacrima medical Prototypes	-

Primary Outcome Measures

Name	Time	Method
Lower Tear Meniscus Height using Optical Coherence Tomography	up to 8 hours

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale score	up to 8 hours

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center, Israel; 🇮🇱 Tel Aviv, Israel